Kornimate/medical-research-clean huggingface dataset:
the efficacy of s-adenosyl methionine (same) versus pentoxiphylline in patients with non-alcoholic steatohepatitis with fibrosis

Conditions: Non-alcoholic Steatohepatitis

Summary: nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient hepatology clinic. secondly our country is the diabetic capital of the world and so the incidence of nafld (non alcoholic fatty liver disease) is expected to rise in the future. it is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. nonalcoholic steatohepatitis (nash) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. approximately 10-20% of patients with nash may progress to cirrhosis. nash is felt to be a major etiology of cryptogenic cirrhosis. around 6230 human studies out of which 49 rcts have been done till date to define the appropriate treatment of nonalcoholic steatohepatitis. however, still a controversy and no recommended treatment available till date. recently published pivens trial has shown that vitamin e has proven benefit in nash. other trials have also shown that pentoxiphylline has shown benefit in the form of histological improvement and biochemical improvement in the form of liver enzymes. role of same has been studied in alcoholic liver disease and showed to improve in both biochemical and histological features. however the usefulness of same in nafld is not known till now. hence this study has been designed.


Eligibility criteria:
inclusion criteria: * age 18 to 70 years * persistently abnormal alt \>1.2 times upper limit of normal * histological evidence of nash (non alcoholic steatohepatitis) on liver biopsy. the minimal criteria for diagnosis of nash included the presence of lobular inflammation and fibrosis up to stage 3 as per burnt stating. exclusion criteria: * alcohol intake of more than 40gm / week with features suggestive chronic liver disease . * other known cause of chronic liver disease like hepatitis b,c, autoimmune liver disease, wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis, primary biliary cirrhosis, psc (primary sclerosis cholangitis). * patient on medication like estrogens, amiodarone, mtx, tamoxifen, att (antitubercular treatment) * pregnancy or lactation * hypersensitivity to methylxanthines (e.g., caffeine, theophylline,) * recent retinal/cerebral hemorrhage * acute myocardial infarction or severe cardiac arrhythmias. * impaired renal function.
ritual ultivision ai cade randomized controlled trial

Conditions: Colon Adenoma; Polyp of Colon; Adenoma Colon

Summary: ultivision ai is a computer-assisted detection (cade) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). ultivision ai cade is indicated for white light colonoscopy only.

ultivision ai contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (cnn). the algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.

Eligibility criteria:
inclusion criteria: 1. age 45 to 75 years; 2. screening or surveillance colonoscopy. 3. iinformed consent exclusion criteria: 1. colorectal cancer; 2. inflammatory bowel disease, including crohn's disease or ulcerative colitis; 3. polyposis syndrome including familial adenomatous polyposis, cowden syndome, linch syndrome, peutz-jeghers syndrome, muityh associated polyposis, familial colorectal cancer type x; 4. positive fecal immunochemical test; 5. use anti-platelet agents or anticoagulants that prevent polyps removal; 6. colon resection, not including the appendix; 7. subject is pregnant or lactating.

Keywords: screening surveillance artificial intelligence colonoscopy
severe acute respiratory syndrome coronavirus 2 re-infection risk and vaccine efficacy in austria

Conditions: COVID-19

Summary: the coronavirus disease 2019 (covid-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus. in this study, we aim to evaluate how strong and how long are individuals in austria after vaccination and/or infection with sars-cov-2 protected against covid-19 disease. in this project, we will analyze national health data from all inhabitants of austria (about 9 million persons) during the covid-19 pandemic. the population of austria will be stratified into different groups according to previous vaccinations against sars-cov-2 and previous sars-cov-2 infections. we primarily evaluate how strong and how long after vaccination against sars-cov-2 and/or infection with sars-cov-2, the risk for covid-19 deaths is reduced or altered as compared to less vaccinated and/or infected persons. as secondary study aims, we perform such analyses also for sars-cov-2 infections, hospitalizations and intensive care unit (icu) stays, with or due to sars-cov-2. these analyses will be performed during different time periods of the covid-19 pandemic, and we will also perform various subgroup analyses as for example according to age and gender. given that antibodies against sars-cov-2 are usually detected after vaccination and/or infection, we will use such antibody data from blood donors in tyrol, to elucidate how well the national health data on sars-cov-2 infections and vaccinations match with the respective antibody data, and how well these antibody data indicate risk of covid-19 deaths and infections. we will calculate the probability of dying due to a sars-cov-2 infection (case/infection fatality rate) for different times of the covid-19 pandemic, in order to document the health threat due to sars-cov-2. based on all these data, we will calculate how many persons have to be vaccinated against sars-cov-2 to prevent one covid-19 death at different times during this covid-19 pandemic. we will consider the respective covid-19 policies such as mask mandates, lock-downs, sars-cov-2 test mandates in our analyses and will evaluate the impact of these policies on covid-19 deaths and diseases. in addition, we will evaluate data on total mortality according to the number of sars-cov-2 vaccinations and/or infections, and we will aim to collaborate with other research groups in order to extend our analyses. in conclusion, the results of this study should provide an overview on the covid-19 pandemic with respect to protection conferred by vaccinations and previous sars-cov-2 infections, as well as the health threat of sars-cov-2, in order to provide knowledge for future covid-19 policy and future pandemics.


Eligibility criteria:
inclusion criteria: - residency in austria. exclusion criteria: - none.
alpha-cell sensitivity to glp-1 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. further it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. with this study we wish to elucidate the potential of glp-1 to increase the sensitivity of the alpha-cell. type 2 diabetic patients and control subjects receive infusions of glp-1 in increasing doses or saline, alpha- and beta-cell responses are measured in blood-samples. during the study plasma-glucose levels are clamped at fasting levels. with this study we hope to elucidate the pathophysiology behind defect glucose tolerance in type 2 diabetes mellitus and further more the potential of glp-1 in treatment of type 2 diabetes mellitus.

background: glucagon-like peptide-1 (glp-1) possesses insulinotropic and glucagonostatic properties, and, therefore, glp-based antidiabetic therapies have been developed. even though the insulinotropic potency of glp-1 has been shown to be reduced in patients with type 2 diabetes mellitus (t2dm), a small dose of glp-1 is capable of normalizing the beta-cell responsiveness to glucose in these patients. the glucagonostatic potency of glp-1 in patients with t2dm is not known, and, furthermore, the capability of glp-1 to reestablish normal glucagon secretion in these patients remains to be elucidated. objective: to investigate the alpha-cell sensitivity to glp-1 in patients with t2dm and to establish if glp-1 is able to reestablish normal glucagon secretion in such patients. method: ten patients with t2dm and ten healthy control subjects are clamped at their fasting blood glucose levels during glp-1 infusions at increasing doses (0.25, 0.5, 1.0 and 2.0 pmol/kg/min) and placebo, respectively. furthermore, the patients will be hospitalized overnight while receiving intravenous insulin and thereafter examined under normoglycaemic conditions. blood are being drawn for analysis of plasma insulin, c-peptide, glp-1 and glucagon. expected results and conclusions: we expect that glp-1 will inhibit glucagon secretion in a dose dependent manner, leading too an increase in glucose turn-over. the results will potentially elucidate the interaction between glp-1 and glucagon secretion and thereby broaden our knowledge on the pathophysiology of t2dm. furthermore, the present study will determine the therapeutic impact of glp-1 on the alpha-cell deficiency characterizing patients with t2dm.

Eligibility criteria:
inclusion criteria: * informed oral and written consent * caucasians aged \> 18 years diagnosed with t2dm due to who criteria. * normal haemoglobin * hba1c 6-10% * bmi 23-35 kg/m2 exclusion criteria: * hepatic disease, alat \> 2 x normal. * diabetic nephropathy, (s-creatinine \>130μm or albuminuria). * diabetic neuropathy (reported) * proliferative diabetic retinopathy (reported) * medical treatment that cannot be paused for 12 hours * insulin- or glitazon treatment

Keywords: glucoseintolerance
pathophysiologic changes in the respiratory system during therapeutic interventions

Conditions: Respiratory Failure

Summary: airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. in this study pressure changes are examined in a mechanical lung model and in a population of icu patients on mechanical ventilation.

airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. in this study such pressure changes are examined in a mechanical lung model and in a population of icu patients on mechanical ventilation. a systematic recording of airway pressures, tidal volumes and blood gases are carried out during ordinary therapeutic procedures requested by the staff physician. no additional study interventions are carried out. the aim of the project is to examine negative effects of pressure/volume changes.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * on mechanical ventilation * daily endotracheal suctioning performed exclusion criteria: * \< 18 years of age * non-invasive ventilation
lateral thigh perforator (ltp) flap for autologous breast reconstruction

Conditions: Breast Cancer

Summary: the lateral thigh perforator (ltp) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. in this prospective study all ltp flap breast reconstructions that have been performed since september 2012 are analyzed. in addition, the surgical refinements that were introduced over the years are reported.


Eligibility criteria:
inclusion criteria: * lateral thigh region suitable as a donor site * abdomen not suitable as donor site * informed consent exclusion criteria: * pre-operative imaging showing no suitable perforators

Keywords: breast reconstruction perforator flap microsurgery
modulation of visually evoked potentials by an antidepressant

Conditions: Depression

Summary: 12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. this study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.


Eligibility criteria:
inclusion criteria: * healthy individuals 18-65 years exclusion criteria: * history of affective oder other psyhiatric disorder * severe medical condition * pregnancy or ineffective contraception * active illicit drug use

Keywords: depression ssri sertraline synaptic plasticity visually evoked potentials
a multicenter and prospective study of screening retinopathy of prematurity in china

Conditions: Premature Birth of Newborn; Retinopathy of Prematurity (ROP); Low Birthweight Infant

Summary: the purpose of the study is to explore the current incidence rate of retinopathy of prematurity (rop) in china and to explore more appropriate screening criteria for rop.


Eligibility criteria:
inclusion criteria: from december 2024 to may 2025, preterm infants (gestational age \<37 weeks) or low birth weight infants (birth weight \<2500 g) who receive their first rop screening at xinhua hospital or partner institutions will be included. exclusion criteria: 1. death before the first screening; 2. death or loss to follow-up before complete retinal vascularization; 3. presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or coats disease; 4. coexisting conditions affecting the classification or staging of rop, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, terson syndrome, or other ocular infections or diseases; 5. poor systemic condition preventing fundus examination; 6. history of ocular trauma or surgery (excluding treatments for rop); 7. poor-quality fundus images; 8. other conditions deemed exclusionary by the investigators.

Keywords: retinopathy of prematurity incidence rate screening
a study of yzj-4729 tartrate injection for the treatment of pain after abdominal surgery

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy and safety of iv yzj-4729 tartrate injection in patients with acute postoperative pain following abdominal surgery.


Eligibility criteria:
inclusion criteria: 1. be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent 2. body mass index (bmi) ≥18 kg/m2 and ≤28 kg/m2. 3. asa i - ii 4. experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a numeric rating scale (nrs) within 4 hours post-surgery exclusion criteria: 1. allergy to opioids and other medications that may be used during the trial. 2. nervous system disorders (e.g. epilepsy) 3. psychiatric disorders (e.g. depression) 4. history of difficult airways 5. random blood glucose ≥11.1 mmol/l 6. uncontrolled blood pressure \[e.g., hypertension (systolic blood pressure ≥160 mmhg, diastolic blood pressure ≥100 mmhg)，or hypotension(systolic blood pressure \<90 mmhg)\] 7. abnormal pulse oxygen saturation (spo2 \<90 %) 8. abnormal liver function or renal function 9. used agents that could affect the analgesic response 10. used agents that could affect drug metabolism 11. has previously participated in another yzj-4729 clinical study
mobile cued adherence therapy (mcat) for blood pressure medication

Conditions: Medication Adherence; Hypertension; Habits

Summary: the goal of this clinical trial is to determine the effectiveness of a novel mobile health-based habit formation intervention for increasing and maintaining adherence to anti-hypertensive (ah) medication among people living with hypertension and indicate medication nonadherence. the main questions it aims to answer are: * can daily incentives for ah pill taking increase and maintain ah medication adherence, control blood pressure, and reduce healthcare utilization and costs? * can daily incentives for ah pill taking, combined with action planning (e.g., "after i drink my morning coffee, i will take my medication.") increase and maintain medication adherence, control blood pressure, and reduce healthcare utilization and costs? * what aspects of daily incentives and/or action planning do participants find most helpful or effective for ah medication adherence? * what barriers exist for participants who receive daily incentives and/or action planning? researchers will compare three study groups: those who only receive daily incentives for the ah pill taking, those who receive daily incentives for ah pill taking combined with action planning, and a control group (who do not receive daily incentives for ah pill taking or action planning). by comparing these three groups, the researchers will be able to determine the effectiveness of the daily incentives with or without action planning for promoting long-term ah medication adherence, reduce healthcare costs, and improve blood pressure. participants will: * complete 5 online surveys over the course of 2 years (baseline, month 4, month 8, month 12, month 24). * submit blood pressure reading for 7 consecutive days after each survey timepoint. * submit photo evidence of their ah pill taking for 4 months (intervention groups only). the highest- and lowest-performing participants in each intervention group will also be invited to complete a 30-minute interview to identify additional factors that contributed to either successful or unsuccessful completion of the intervention.


Eligibility criteria:
eligibility criteria: * aged 18 years or older * currently diagnosed with hypertension (either stage i or stage ii hypertension) * able to read/write/understand english * have daily access to a smartphone * engaged in hypertension care: already been prescribed hypertension medication for a minimum of 12 months at the time of study enrollment * demonstrated ah medication nonadherence by having over 73 days without documented ah medication prescription coverage (observable in arizona health care cost containment system (ahcccs) prescription drugs claims) in the past 12 months (i.e. \<80% mean adherence)

Keywords: habits medication adherence hypertension blood pressure mobile app
pharmacokinetic study of fentanyl 400 µg sublingual spray, actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously (iv)

Conditions: Pain

Summary: the objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

this was a phase i, single-dose, open-label, randomized, 3-period, 3-treatment cross over study in which 21 healthy subjects received single doses of fentanyl 400 µg sublingual spray, actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously following a 10-hour overnight fast. there was a 7 day washout period between treatments.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-breast-feeding female between the ages of 18-55 inclusive. * body mass index (bmi) between 18-30 kg/m\^2, inclusive, and body weight of at least 60 kg (132 lbs). * subject was healthy according to the medical history, laboratory results, and physical examination. exclusion criteria: * had a presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results. * had a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ecg), or clinical laboratory results at screening. * had a significant history of hypersensitivity to opioid analgesics, fentanyl or any related products, naltrexone, or severe hypersensitivity reactions (like angioedema) to any drugs. * had a significantly abnormal diet during the 4 weeks preceding the first dose of study medication. * had donated blood or plasma within 30 days prior to the first dose of study medication or during the course of this study. * had participated in another clinical trial within 30 days prior to the first dose of study medication or during the course of this study. * had used any over-the-counter (otc) medication, including nutritional supplements, within 7 days prior to the first dose of study medication or during the course of this study. * had used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication or during the course of this study. * had used enzyme altering drugs such as barbiturates, corticosteroids, phenothiazines, cimetidine, carbamazepine, etc, within 30 days prior to the first dose of study medication or during the course of this study. * had used opioid analgesics within the last 30 days.
guselkumab vs golimumab in psa tnf inadequate responder patients

Conditions: Psoriatic Arthritis

Summary: the trial is an open-label randomized study that will examine whether switching to a selective il23 inhibitor (guselkumab) is more effective than switching to a second tnfi (golimumab) among patients with psa who have an inadequate response to a tnfi.

the primary aim of the trial will be to determine, among psoriatic arthritis (psa) patients with an inadequate response (ir) to a tumor necrosis factor inhibitor (tnfi), whether switching to a new mechanism of action (moa), specifically guselkumab (gus), a selective interleukin 23 inhibitor (il23i) targeting the p19 subunit, is more effective than switching to another tnfi. the primary hypothesis of this study is that switching to a new moa may be more effective than switching to a second tnfi. this will be the first trial to test such a switch in psa patients. additionally, the proposed study will address the effectiveness of a new therapy, gus, in a clinical practice setting among patients who are tnf ir.

Eligibility criteria:
inclusion criteria: 1. psoriatic arthritis meeting caspar criteria; 2. active psoriatic arthritis defined by at least 1 swollen joint; 3. cdapsa score ≥ 10; see also exclusion #4 - cdapsa must be \> 14 in patients without psoriasis. 4. using a tnfi or previously used a single tnfi historically and either never responded or lost response (tnf ir) and planning to switch to a new biologic therapy; 5. if using an oral small molecule/csdmard (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; use of up to two osm/csdmards is allowed. 6. if using nsaids, glucocorticoids (\<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks prior to screening/baseline 1 and remain on a stable dose during the study; 7. age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to psa vs oa). exclusion criteria: 1. prior exposure to golimumab or another non-tnfi biologic (il12/23i, jaki, an il17i, or an il23i); prior exposure to a tyk2i is acceptable, but cannot be used during course of the study; 2. an adverse event that precludes use of another tnfi (development of drug-induced sle, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a tnfi; 3. use of moderate to high dose glucocorticoids (\>10 mg); 4. already meets the primary endpoint at baseline; \[cdapsa low disease activity ≤ 14; iga of psoriasis 0/1\] in patients with psoriasis, cdapsa can be 10-14 if the investigator global assessment of psoriasis ≥ 2. in patients without psoriasis, cdapsa must be \> 14 to meet eligibility requirements. 5. currently pregnant or actively trying to conceive.

Keywords: psoriatic arthritis psa